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Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02739204
Recruitment Status : Unknown
Verified April 2016 by China Medical University Hospital.
Recruitment status was:  Recruiting
First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
China Medical University Hospital

Brief Summary:
The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Drug: Celecoxib Phase 2

Detailed Description:
Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Celecoxib
Combination of concurrent radiotherapy and/or Cisplatin with or without Celcoxib
Drug: Celecoxib
200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months
Other Name: Celebrex




Primary Outcome Measures :
  1. Relapse-free recurrence [ Time Frame: 3 year relapse-free recurrence ]
    3-year follow-up after 6-month treatment of Celecoxib


Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: 3 year relapse-free survival ]
    3-year follow-up after 6-month treatment of Celecoxib



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. OSCC patients with T1,2/ N0 and without pathological risk features
  2. OSCC patients with T1,2/ N0,1 and pathological risk features
  3. OSCC patients with T4a/ N2,3

Exclusion Criteria:

  1. Pregnant women paitents
  2. Taiwanese aboriginal patients
  3. Not primary OSCC patients
  4. OSCC patients with dysfunction of liver and/or kidneys

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739204


Contacts
Contact: Ying-Chin Ko, MD-PhD 886-4-22052121 ext 7322 ycko0406@gmail.com

Locations
Taiwan
Department of Otolaryngology Recruiting
Taichung, Taiwan, 40447
Contact: Ming-Hsul Tsai, M.D. Ph.D.    886-4-22052121 ext 4436    minghsui@mail.cmuh.org.tw   
Principal Investigator: Chun-Hung Hua, M.D.         
Sponsors and Collaborators
China Medical University Hospital
Ministry of Health and Welfare, Taiwan
Investigators
Study Chair: Ying-Chin Ko, MD-PhD Graduate Institute of Clinical Medical Science, China Medical University, Taiwan

Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02739204     History of Changes
Other Study ID Numbers: CMUH102-REC1-071
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by China Medical University Hospital:
Celecoxib
Relapse-free OSCC patient
Recurrence
Survival
Prognosis

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents